Kyowa Hakko Kogyo Co., Ltd and Amgen entered into an agreement under which Amgen will receive an exclusive license to develop and commercialize Kyowa Hakko's humanised monoclonal antibody KW-0761 worldwide, except in Japan, Korea, China and Taiwan. Kyowa Hakko will retain the development and commercialization rights in these countries.

Under the terms of the deal, Amgen will make an upfront payment to Kyowa Hakko of $100 million. Kyowa Hakko could receive up to $420 million in additional payments, including development, approval and sales milestones. Kyowa Hakko will also be entitled to receive double digit royalties on sales.

KW-0761 is currently being studied in inflammation and oncology settings. Kyowa Hakko has completed phase I studies of KW-0761 in healthy volunteers and allergic rhinitis patients, and is currently conducting phase I studies of KW-0761 in lymphoma patients.

Amgen will initially acquire rights in all non-oncology indications, and Kyowa Hakko will continue its development activities in oncology until the completion of phase IIa. At that time, Amgen may elect to reimburse Kyowa Hakko for its oncology-related development costs, expand its license to include oncology and assume the development and commercialization of KW-0761 in oncology settings.

The agreement is subject to approval from the Federal Trade Commission and will be effective immediately upon such approval.

CCR4 is a chemokine receptor that binds specifically to its ligands TARC and MDC, and participates in the control of T cell migration. CCR4 is expressed mainly on Th2-type helper T cells and regulatory T cells in normal conditions. CCR4+ T cells are implicated in the pathology of asthma and other inflammatory diseases and T-cell malignancies.

KW-0761 is a humanised monoclonal antibody targeting CCR4 utilizing the Potelligent technology platform for the development of antibody-dependent cell-mediated cytotoxicity- (ADCC) enhanced antibodies.

ADCC activity is an important immune mechanism that permits immune cells to kill targets, e.g. cancer cells. Enhancement of this activity is one promising approach in the next generation of antibody technologies.

The Potelligent technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody. Research shows that Potelligent technology significantly enhances the ADCC activity of antibodies in vitro, thereby increasing the potential for improved activity in vivo.

Kyowa Hakko is a biotechnology-based company focused on two businesses: pharmaceutical operations engaged in the research and development, manufacturing, and marketing of prescription drugs; and bio-chemical operations that handle a variety of products such as amino acids, nucleic acids, and nutritional supplements/healthcare products.